Status:
COMPLETED
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Ventricular Tachyarrhythmias
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system. A maximum of 10 subjects were to be enrolled and follow...
Eligibility Criteria
Inclusion
- replacement of an existing transvenous implantable cardioverter defibrillator (ICD) system
- American College of Cardiology/American Heart Association/Heart Rhythm Society (ACC/AHA/HRS) Class I or II indications for ICD implantation
- Age \>= 18 years
- Appropriate pre-operative Electrocardiogram (ECG) as measured with a specially developed template
Exclusion
- Subjects unable or unwilling to provide informed consent
- Any condition which precludes the subject's ability to comply with the study requirements
- Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
- Participation in another investigational device trial at any time during the conduct of the S-ICD system trial without written consent from the sponsor.
- Patients with a serious medical condition and life expectancy of less than one year.
- Patients with documented spontaneous and frequently recurring ventricular tachyarrhythmias (VT) that is reliably terminated with anti-tachycardia pacing
- Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
- Patients with chronic renal failure, i.e. with a creatinine level of \>2.5 mg/dl unless prescribed drug therapy known to increase creatinine levels in which case the value should be \<= 3mg/dl
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00853645
Start Date
July 1 2008
End Date
September 1 2008
Last Update
July 6 2021
Active Locations (2)
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1
Auckland City Hospital
Auckland, New Zealand, 1001
2
Christchurch Hospital
Christchurch, New Zealand, 8140